AzTrials
AzTrials

HBVNCT07007286

Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer

An observational study of HBV and HCC, run by Peking University First Hospital at 555 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
HBV, HCC
What is being tested?
ETV,TDF,TAF,TMF combination with PEG IFNα-2b and ETV,TDF,TAF or TMF
How many people
1,500 participants
Where
555 sitesChina
Study dates
Jun 2025to Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who meet the inclusion criteria but do not meet the exclusion criteria were screened from multiple centers nationwide.

Who may be able to join

  • (1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.

Who cannot join

  • (1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

555 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Guiqiang Wang contact

01066119025

bdyyec@163.com

300 sites in 1 country

China300 sites

  • Anfu County People's Hospital

    Anfu

    Zhiyun Peng

  • Ankang Central Hospital

    Ankang

    Xuemei Li

  • Ankang Hospital of Traditional Chinese Medicine

    Ankang

    Xiang Cui

  • Anning Hospital of Traditional Chinese Medicine

    Anning

    Qiuhong Liu

  • Anqing First People's Hospital

    Anqing

    Feng He

  • Anqing Municipal Hospital

    Anqing

    Zhenjun Liu

  • Anshan Infectious Disease Hospital

    Anshan

    Yang Xu

  • Anyue County People's Hospital

    Anyue

    Guanglin Pu

  • Affiliated Hospital of Youjiang Medical University for Nationalities

    Baise City

  • Baoding First Central Hospital

    Baoding

    Guangzhou Gao

  • Baoding People's Hospital

    Baoding

    Musong Li

  • Baotou Central Hospital

    Baotou

    Jing Wang

  • China National Medicines (CNM) Northern Hospital

    Baotou

    Yongqing Ren

  • The Third Staff Hospital of Baotou Steel Group

    Baotou

    Kun Yan

  • Beihai People's Hospital

    Beihai

    Feng Long

  • Beijing Daxing District People's Hospital

    Beijing

    Xia Liu

  • Beijing Ditan Hospital, Capital Medical University

    Beijing

    Yao Xie

  • Beijing Ditan Hospital

    Beijing

    Yao Xie

  • Beijing Fangshan District First Hospital

    Beijing

    Xiuying Xie

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing

    Li Li

  • Beijing Huaxin Hospital

    Beijing

    Qinbing Zeng

  • Beijing Liangxiang Hospital, Fangshan District

    Beijing

    Juan Zhou

  • Beijing Tsinghua Changgung Hospital

    Beijing

    Ming Yang

  • Beijing You'an Hospital, Capital Medical University

    Beijing

    Sujun Zheng

  • Beijing You'an Hospital

    Beijing

    Sujun Zheng

  • Dongfang Hospital, Beijing University of Chinese Medicine

    Beijing

  • Dongzhimen Hospital, Beijing University of Chinese Medicine

    Beijing

    Hongbo Du

  • Peking University People's Hospital

    Beijing

    Bo Feng

  • Peking University Third Hospital

    Beijing

    Ming Lu

  • Shunyi Hospital of Traditional Chinese Medicine, Beijing

    Beijing

    Li Li

  • The Fifth Medical Center of PLA General Hospital

    Beijing

    Junliang Fu

  • Wangfu Hospital of Integrated Traditional Chinese and Western Medicine

    Beijing

    Lin Zhu

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing

    Yinqiang Zhang

  • Xuanwu Hospital, Capital Medical University

    Beijing

    Geng Tian

  • Bengbu Fifth People's Hospital

    Bengbu

    Zheng Liu

  • Guzhen County Hospital of Traditional Chinese Medicine

    Bengbu

  • Guzhen County People's Hospital

    Bengbu

    Tong Wang

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Chuanmiao Liu

  • Benxi Sixth People's Hospital

    Benxi

    Hua Jin

  • Beihai Tuberculosis Prevention and Treatment Hospital

    Bihua

    Bihua Gao

  • Binzhou Central Hospital

    Binzhou

    Ying Jiang

  • Binzhou People's Hospital

    Binzhou

    Kai Zuo

  • Bozhou Hospital of Traditional Chinese Medicine

    Bozhou

    Daping Du

  • Bozhou People's Hospital

    Bozhou

    Lan Ma

  • Lixin County People's Hospital

    Bozhou

    Jing Xu

  • Mengcheng First People's Hospital

    Bozhou

    Pengfei Xie

  • Cangzhou Third Hospital

    Cangzhou

    Aihua Gao

  • The First Hospital of Jilin University

    Changchun

    Yanhang Gao

  • Changji Branch of the First Affiliated Hospital of Xinjiang Medical University

    Changji

    Min Chen

  • Changji Hui Autonomous Prefecture People's Hospital

    Changji

    Jiangtao Liu

  • Changle County People's Hospital

    Changle, Shandong

  • Changxing County People's Hospital

    Changxing

    Xiaoxue Xia

  • Changzhi People's Hospital

    Changzhi

    Hong Wu

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi

    Suling Chen

  • Changzhou Third People's Hospital

    Changzhou

    Yuan Xue

  • Yizheng People's Hospital

    Changzhou

    Hongxia Ma

  • Chaoyang Fourth Hospital

    Chaoyang

    Jinghai Du

  • Kazuo County Central Hospital

    Chaoyang

    Hongguang Fan

  • Chengdu Fifth People's Hospital

    Chengdu

    Xiaomei Xu

  • Chengdu Public Health Clinical Medical Center

    Chengdu

    Li Zhu

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu

    Xingxiang Yang

  • West China Hospital, Sichuan University

    Chengdu

    Xuezhong Lei

  • Chifeng Baoshan Hospital

    Chifeng

    Yuqin Wan

  • Chifeng Songshan Traditional Chinese Medicine & Mongolian Medicine Hospital

    Chifeng

    Changling Dong

  • Chifeng Tumor Hospital

    Chifeng

    Lichun Yang

  • Chizhou People's Hospital

    Chizhou

    Xiaoling Liu

  • Mingguang People's Hospital

    Chuzhou

    Zhen Fang

  • Dali Bai Autonomous Prefecture People's Hospital

    Dali

    Huiyong Su

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Ying Zhu

  • Dandong Sixth People's Hospital

    Dandong

    Hui Liu

  • Daqing Second Hospital

    Daqing

    Zhen Lü

  • China National Medicines & Health Products Datong Coal Mine Group General Hospital

    Datong

    Jingning Yang

  • Datong Fourth People's Hospital

    Datong

    Riwang Hu

  • Donggang Central Hospital

    Donggang

    Ming Jiang

  • Dongguan Eastern Central Hospital

    Dongguan

    Dongben Gao

  • Dongguan Ninth People's Hospital

    Dongguan

    Lihua Zhang

  • Dongtai People's Hospital

    Dongtai

    Xiaoqiang Zhong

  • Dongying Hospital of Traditional Chinese Medicine

    Dongying

    Xiangmeng Cao

  • Dongying People's Hospital

    Dongying

    Pengyan Li

  • Shengli Oilfield Central Hospital

    Dongying

    Xue Feng

  • Jianshi County People's Hospital

    Enshi

    Zaixing Huang

  • Lichuan Traditional Chinese Medicine Hospital for Ethnic Minorities

    Enshi

    Xiaoyu Zhao

  • Ezhou Central Hospital

    Ezhou

    Wenjin Sun

  • Fengcheng People's Hospital

    Fengcheng

    Feibing Luo

  • Fenyang Hospital

    Fenyang

    Yaosheng Quan

  • Foshan Hospital of Traditional Chinese Medicine

    Foshan

    Xiaojun Ma

  • Sanshui Hospital of Zhujiang Hospital, Southern Medical University

    Foshan

    Yinhui Liu

  • Shunde Hospital Affiliated to Jinan University

    Foshan

    Bin Liu

  • The Eighth Affiliated Hospital of Southern Medical University

    Foshan

    Hong Li

  • The Fourth People's Hospital of Foshan

    Foshan

    Weijin Gong

  • Fuxin Infectious Disease Hospital

    Fuxin

    Xinyu Li

  • Fuyang Fifth People's Hospital

    Fuyang

    Xinggang Fan

  • Fuyang Hospital Affiliated to Anhui Medical University

    Fuyang

    Lizhou Zhang

  • Fuyang People's Hospital

    Fuyang

    Baogui Wang

  • Fuyang Second People's Hospital

    Fuyang

    Ming Li

  • Linquan County People's Hospital

    Fuyang

    Changfeng Wu

  • Taihe County Hospital of Traditional Chinese Medicine

    Fuyang

    Lianye Zhang

  • Jinxi County People's Hospital

    Fuzhou

    Jianping Jiang

  • Lichuan County People's Hospital

    Fuzhou

    Hongqi Yan

  • Linchuan District First People's Hospital

    Fuzhou

    Yansun Wu

  • Nanfeng County People's Hospital

    Fuzhou

    Xin Zeng

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

    Yueyong Zhu

  • Dingnan County First People's Hospital

    Ganzhou

    Ping Chen

  • Ganzhou Fifth People's Hospital

    Ganzhou

    Yingmin Luo

  • Ganzhou People's Hospital

    Ganzhou

    Jie Liu

  • Yudu County People's Hospital

    Ganzhou

    Yonghong Deng

  • Gaomi People's Hospital

    Gaomi

    Jinxin Sun

  • Guangzhou Eighth People's Hospital, Guangzhou Medical University

    Guangzhou

    Keli Yang

  • Guangzhou First People's Hospital

    Guangzhou

    Qi Zhan

  • Guangzhou Medical University Affiliated Panyu Central Hospital

    Guangzhou

    Yumei Chen

  • Huadu District People's Hospital, Guangzhou

    Guangzhou

    Peiyan Xu

  • Nansha District People's Hospital, Guangzhou

    Guangzhou

    Yangli Zhang

  • Panyu District Maternal and Child Health Hospital, Guangzhou

    Guangzhou

    Yankun He

  • Shijing People's Hospital, Baiyun District, Guangzhou

    Guangzhou

    Liujiao Fang

  • The Fourth Affiliated Hospital of Guangzhou Medical University

    Guangzhou

    Qiwen Wu

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou

    Xingfei Pan

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou

    Chuangguo Yang

  • Guilin Hospital of Traditional Chinese Medicine

    Guilin

    Ming Jiang

  • The Third People's Hospital of Guilin

    Guilin

    Yongchao Xian

  • Xing'an County People's Hospital

    Guilin

    Huanwen Chen

  • Hainan Provincial People's Hospital

    Haikou

    Li Shi

  • Hailin People's Hospital

    Hailin

    Hongwei Wang

  • Hami Central Hospital

    Hami

    Chuanjian Shi

  • Xinjiang Production and Construction Corps 13th Division Hongxing Hospital

    Hami

    Jin Yang

  • Handan Central Hospital

    Handan

    Huanhuan Song

  • Handan First Hospital

    Handan

    Hexian Cui

  • Handan Fourth Hospital

    Handan

    Zhiguo Sun

  • Handan Infectious Disease Hospital

    Handan

    Zhenhai Ning

  • Linzhang County People's Hospital

    Handan

    Guocheng Wang

  • Wei County People's Hospital

    Handan

    Chao Gao

  • Yongnian District First People's Hospital

    Handan

    Xuelian Li

  • Hangzhou Xixi Hospital

    Hangzhou

    Wenjun Ma

  • Lin'an District First People's Hospital

    Hangzhou

    Yuefei Shen

  • Linping District Hospital of Traditional Chinese Medicine

    Hangzhou

    Yuejiao Cao

  • The Second Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou

    Yi Zheng

  • Chenggu County People's Hospital

    Hanzhong

    Jin Li

  • Hanbin District First Hospital

    Hanzhong

    Bengong Ye

  • Hanzhong Second People's Hospital

    Hanzhong

    Weijia Zhao

  • Yang County People's Hospital

    Hanzhong

    Hong Chang

  • Acheng District People's Hospital of Harbin

    Harbin

    Haisheng Song

  • Harbin First Hospital

    Harbin

    Linlin Na

  • Harbin Sixth Hospital

    Harbin

    Lin Zhang

  • Heilongjiang Provincial Hospital

    Harbin

    Xiaoli Hu

  • The First Affiliated Hospital of Harbin Medical University

    Harbin

    Guolin Chen

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin

    Lihua Zhong

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin

    Ming Liang

  • Gu'an County Hospital of Traditional Chinese Medicine

    Hebei

    Yubo Zhang

  • Anhui Provincial Hospital

    Hefei

    Hongliang He

  • Hefei First People's Hospital Binhu Branch

    Hefei

    Limin Liang

  • Hefei First People's Hospital

    Hefei

    Jishun Zheng

  • Hefei Second People's Hospital

    Hefei

    Jiling Wang

  • Hefei Third People's Hospital

    Hefei

    Chunhua Fang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Liyu Zhu

  • Hegang Infectious Disease Hospital

    Hegang

    Chunping Liu

  • Hegang Mining General Hospital

    Hegang

    Tao Wang

  • Beian First People's Hospital

    Heihe

    Yahui Ma

  • Heihe First People's Hospital

    Heihe

    Xiujuan Chen

  • Qitaihe Infectious Disease Hospital

    Heilongjiang, Heilongjiang

    Bohui Yuan

  • Hengshui Third People's Hospital

    Hengshui

    Suoxiang Zhang

  • Hotan Prefecture Specialized Hospital for Infectious Diseases

    Hetian

    Wubulai Aishan Maimaitijiang

  • Heze Municipal Hospital

    Heze

    Fangqi Ge

  • Hezhou People's Hospital

    Hezhou

    Fan Li

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

    Zhen Ma

  • Hohhot Second Hospital

    Hohhot

    Jianming Li

  • Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

    Hohhot

    Ruixiu Xiao

  • The 969th Hospital of the Joint Logistics Support Force

    Hohhot

    Cai Chen

  • The Fourth Hospital of Inner Mongolia Autonomous Region

    Hohhot

    Xiaoying Xu

  • Hongze District People's Hospital

    Huai'an

    Jian Tan

  • Huai'an Fifth People's Hospital

    Huai'an

    Xuezhen Zhai

  • Huai'an Fourth People's Hospital

    Huai'an

    Chun Lü

  • Huai'an No. 82 Hospital

    Huai'an

    Zhaorong Jiang

  • Huainan First People's Hospital

    Huainan

    Yanzhong Wang

  • Huangshan Huangshan People's Hospital

    Huangshan City

    Xianjin Xie

  • Huangshan People's Hospital

    Huangshan City

    Yongjin Yang

  • Qimen County People's Hospital

    Huangshan City

    Xiang Zhang

  • Xiuning County People's Hospital

    Huangshan City

    Wei Zhang

  • Daye People's Hospital

    Huangshi

    Wen Chen

  • Huangshi Central Hospital

    Huangshi

    Zhiyong Zhang

  • Huangshi Hospital of Traditional Chinese Medicine

    Huangshi

    Zhilin Shao

  • Yangxin County People's Hospital

    Huangshi

    Xunhao Wang

  • Huazhong University of Science and Technology

    Hubei

    Zhengang Zhang

  • Huozhou Coal & Electricity Group General Hospital Co., Ltd.

    Huozhou, Shanxi

  • Huozhou People's Hospital, Huozhou Medical Group

    Huozhou, Shanxi

    Wenfei Zhang

  • Huozhou People's Hospital

    Huozhou, Shanxi

    Wenfei Zhang

  • Ji'an Central People's Hospital

    Ji’an

    Haibin Yin

  • Jiamusi Infectious Disease Hospital

    Jiamusi

    Mingyou Li

  • Jiangmen Central Hospital

    Jiangmen

    Gang He

  • Xinhui People's Hospital

    Jiangmen

    Qingxia Zhou

  • Jianping County Hospital

    Jianping

    Honghua Kang

  • Tongji University Affiliated Oriental Hospital Jiaozhou

    Jiaozhou

    Huimin Li

  • Fenxi Mining Group Employees General Hospital

    Jiexiu, Shanxi

    Shuguang Hu

  • Jiexiu Medical Group People's Hospital

    Jiexiu, Shanxi

    Xiaobin Luo

  • Affiliated Hospital of Beihua University

    Jilin City

    Dalin Hao

  • Jilin City Infectious Disease Hospital

    Jilin City

    Yujie Wang

  • Jilin Provincial Hepatobiliary Hospital

    Jilin City

    Hui Chen

  • Qingdao Jimo District People's Hospital

    Jimo

    Jihong Zhang

  • Jinan People's Hospital

    Jinan

    Daojie Yan

  • Jiyang District Hospital of Traditional Chinese Medicine

    Jinan

    Jian Yao

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan

    Wanhua Ren

  • Shandong Provincial Public Health Clinical Center

    Jinan

    Xiaoying Li

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan

    Yong An

  • The Second Hospital of Shandong University

    Jinan

    Tao Li

  • Gaoping People's Hospital

    Jincheng

    Dongdong Cui

  • Jincheng People's Hospital

    Jincheng

    Yunlei Liang

  • Jincheng Third People's Hospital

    Jincheng

    Junmei Han

  • Zezhou County People's Hospital

    Jincheng

    Junjun Bi

  • Gong'an County People's Hospital

    Jingzhou

    Shijin Tian

  • Jingzhou Central Hospital

    Jingzhou

    Zheng Yang

  • The First People's Hospital of Jingzhou, Hubei

    Jingzhou

    Liya Zhu

  • Jinhua Municipal Central Hospital

    Jinhua

    Haijun Chen

  • Jining Public Health Medical Center

    Jining

    Chunsheng Hou

  • Jinxiang County People's Hospital

    Jining

  • Jinxian County People's Hospital

    Jinxian

    Sangen Chen

  • Jinzhong First People's Hospital

    Jinzhong

    Liqing An

  • Shanxi Coking Coal Fenxi Mining Group Employees General Hospital

    Jinzhong

    Shuguang Hu

  • Jinzhou Central Hospital

    Jinzhou

    Yuanyuan Wang

  • Jinzhou Infectious Disease Hospital

    Jinzhou

    Yanhui Sun

  • Jiujiang Hospital of Traditional Chinese Medicine

    Jiujiang

    Yulin Chen

  • Jiujiang Third People's Hospital

    Jiujiang

    Zheng Wo

  • Jixi Infectious Disease Hospital

    Jixi

    Zhenjun Li

  • Juxian People's Hospital

    Junxian, Shandong

    Shanzhu Yu

  • Karamay Central Hospital

    Karamay

    Xin Da

  • Yunnan Provincial People's Hospital

    Kunming

    Jiawei Geng

  • Laixi People's Hospital

    Laixi

    Bochen Wang

  • Laizhou People's Hospital

    Laizhou

    Ruifen Chi

  • Lanzhou Petrochemical General Hospital

    Lanzhou

    Gang Yin

  • Lanzhou Second People's Hospital

    Lanzhou

    Xuehua Yan

  • The Second Hospital of Lanzhou University

    Lanzhou

    Rui Zhao

  • Dongfang Hospital of Lianyungang

    Lianyungang

    Shanmei Dai

  • Guanyun County Hospital of Traditional Chinese Medicine

    Lianyungang

    Minfei Wang

  • Guanyun County People's Hospital

    Lianyungang

    Qin Yang

  • Lianyungang Dongfang Hospital

    Lianyungang

    Shanmei Dai

  • Lianyungang First People's Hospital

    Lianyungang

    Tingting Zhang

  • Houma People's Hospital

    Linfen

    Shujun Gao

  • Linfen Central Hospital

    Linfen

    Yuefeng Chai

  • Linfen Second People's Hospital

    Linfen

    Hongxia Li

  • Linfen Third People's Hospital

    Linfen

    Fenxiang Li

  • Xiangfen County People's Hospital

    Linfen

    Wenyan Jing

  • Yaodu District People's Hospital

    Linfen

    Hui Zhang

  • Linkou County People's Hospital

    Linkou

    Li Sun

  • Hezheng County People's Hospital

    Linxia

    Guozhong Li

  • Linyi Hospital of Traditional Chinese Medicine

    Linyi

    Hezheng Shen

  • Linyi People's Hospital

    Linyi

    Feng Gao

  • Lishui Central Hospital

    Lishui

    Jie Yang

  • Liuzhou People's Hospital

    Liuzhou

    Shufang Yuan

  • Liuzhou Workers' Hospital

    Liuzhou

    Qian Guo

  • Longnan First People's Hospital

    Longnan

    Hong Zheng

  • Liancheng County Hospital

    Longyan

    Yanqin Wu

  • Longyan People's Hospital

    Longyan

    Jining Xu

  • Longyan Second Hospital

    Longyan

    Qingdong Tong

  • Tingzhou Hospital of Changting County

    Longyan

    Yunyan Wu

  • Wuping County Hospital

    Longyan

    Jiansheng Huang

  • Affiliated Hospital of West Anhui Health Vocational College

    Lu'an

    Zhenxiang Zhu

  • Huoqiu First People's Hospital

    Lu'an

    Qingming Duan

  • Huoqiu Second People's Hospital

    Lu'an

    Lin Dong

  • Huoshan County Hospital

    Lu'an

    Jun Zhan

  • Jinzhai County Hospital of Traditional Chinese Medicine

    Lu'an

    Wu Liu

  • Lu'an Fourth People's Hospital

    Lu'an

    Minglan Tao

  • Lu'an Hospital of Traditional Chinese Medicine

    Lu'an

    Wei He

  • Lu'an People's Hospital

    Lu'an

    Jianguo Rao

  • Lu'an Yeji District People's Hospital

    Lu'an

    Lianghuan Geng

  • Lvliang People's Hospital

    Lüliang

    Xiaoling Li

  • Wenshui County People's Hospital

    Lüliang

    Lizhen Hou

  • Ma'anshan Fourth People's Hospital

    Ma’anshan

  • The Second Affiliated Hospital of Wannan Medical College

    Ma’anshan

    Wenjun Yao

  • Macheng People's Hospital

    Macheng

    Jingfeng Chen

  • Huazhou People's Hospital

    Maoming

    Bozhi Chen

  • Meishan People's Hospital

    Meishan

    Junying Liu

  • Mudanjiang Kang'an Hospital

    Mudanjiang

    Yanxia Zhang

  • Mudanjiang Second People's Hospital

    Mudanjiang

    Weiwei Pan

  • Jiangxi Provincial People's Hospital

    Nanchang

    Yuanmei Che

  • Nanchang County People's Hospital

    Nanchang

    Chengyun Yang

  • Nanchang Ninth Hospital

    Nanchang

    Zhicheng Zhang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Xiaoping Wu

  • The Second Affiliated Hospital of Nanchang University

    Nanchang

    Shuilin Sun

  • Nanbu County People's Hospital

    Nanchong

    Tonggang Liu

  • Nangong People's Hospital

    Nangong

    Peng Gao

  • Jiangsu Provincial People's Hospital

    Nanjing

    Chuanlong zhu

  • Lishui District People's Hospital

    Nanjing

    Chunyan Fan

  • Nanjing Drum Tower Hospital

    Nanjing

    Jie Li

  • Nanjing Hospital of Traditional Chinese Medicine

    Nanjing

    Yanliang Zhang

  • Nanjing Second Hospital

    Nanjing

    Wei Ye

  • Nanjing Tianyinshan Hospital

    Nanjing

    Maorong Wang

  • Qinhuai Medical District of Eastern Theater General Hospital

    Nanjing

    Lecheng Yu

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing

    Jie Yin

  • Zhongda Hospital

    Nanjing

    Qun Zhang

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

    Yanhong Yu

  • The First Affiliated Hospital of Guangxi University of Chinese Medicine

    Nanning

    Fuli Long

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning

    Keli Wei

  • The Second People's Hospital of Nanning

    Nanning

    Ziyu Liang

  • Jianyang First Hospital of Nanping

    Nanping

    Xiaoying Wang

  • Nanping First Hospital

    Nanping

    Yuanzhong Gong

  • Zhenghe County Hospital

    Nanping

  • Affiliated Hospital of Nantong University

    Nantong

  • Haimen District People's Hospital

    Nantong

    Aidong Xu

  • Nantong Third People's Hospital

    Nantong

    Xianjin Liu

  • Qidong Third People's Hospital

    Nantong

  • Bairin Left Banner People's Hospital

    Neimeng

    Yanping Gao

  • Hulunbuir People's Hospital

    Neimeng

    Xin Lu

  • Morin Dawa Daur Autonomous Banner People's Hospital

    Neimeng

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About this study

Official title: A Real-World Study on Reducing the Risk of Liver Cancer in Chronic Hepatitis B Patients With a Family History of HBV-Related Liver Cancer.

This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.

Conditions
HBV, HCC
Being tested
ETV,TDF,TAF,TMF combination with PEG IFNα-2b, ETV,TDF,TAF or TMF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETV,TDF,TAF,TMF combination with PEG IFNα-2bDrug

    The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

  • ETV,TDF,TAF or TMFDrug

    The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

Study groups in NCT07007286
Study groupRoleWhat they receive
PEG IFNα-2b GroupNot described
Receives: Drug: ETV,TDF,TAF,TMF combination with PEG IFNα-2b
Nucleos(t)ide Monotherapy GroupNot described
Receives: Drug: ETV,TDF,TAF or TMF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year incidence of hepatocellular carcinoma (HCC)

    Measured: From the start of antiviral treatment to 5 years of follow-up.

Secondary outcomes (10)

  1. HBsAg seroclearance rate

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  2. HBeAg seroclearance rate

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  3. HBV DNA level

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  4. HBsAg level

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  5. HBeAg level

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  6. Proportion of patients with improved or progressed liver fibrosis

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  7. Median time to cirrhosis

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  8. Median time to decompensated cirrhosis

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  9. Median time to HCC

    Measured: From the start of antiviral treatment to 5 years of follow-up.

  10. Overall survival (OS)

    Measured: From the start of antiviral treatment to 5 years of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJan 2032 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007286
Sponsor's protocol ID
2025086
Status last verified
May 2025
First submitted
28 May 2025
Last updated
5 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of HBV and HCC, run by Peking University First Hospital at 555 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 555 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guiqiang Wang (01066119025, bdyyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year incidence of hepatocellular carcinoma (HCC) (time frame: From the start of antiviral treatment to 5 years of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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